Protocol summary
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Study aim
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The aim of this study is to determine the effects of zinc supplementation on biomarkers of inflammation and oxitative and pregnancy outcomes in gestational diabetes.
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Design
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Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers.
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Settings and conduct
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Among patients with GDM referred to Naghavi outpatient Clinic affiliated to Kashan University of Medical Sciences, 50 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with preeclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study.
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Intervention groups
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Patients will be assigned into two groups to receive zinc supplements (n=25) or placebo (n=25).
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Main outcome variables
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Outcomes: Maternal hs-CRP and newborns PPAR-gamma (primary outcomes), maternal other biomarkers of inflammation and oxidative stress outcomes (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201505095623N42
Registration date:
2015-05-22, 1394/03/01
Registration timing:
retrospective
Last update:
2019-08-11, 1398/05/20
Update count:
1
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Registration date
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2015-05-22, 1394/03/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kashan University of Medical Sciences
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Expected recruitment start date
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2014-10-27, 1393/08/05
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Expected recruitment end date
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2014-11-26, 1393/09/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of zinc supplementation on biomarkers of inflammation, stress oxidative and pregnancy outcomes in women with gestational diabetes
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Public title
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Effect of zinc in treatment of gestational diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women aged 18-40 years
diagnosed with GDM at 24-28 weeks' gestation
Exclusion criteria:
The use of substitute treatments including hormone or vitamin supplements
patients with preeclampsia
complete bed rest (CBR)
intra uterine fetal death (IUFD)
placenta abruption
preterm delivery
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-10-25, 1393/08/03
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Ethics committee reference number
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3534
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes
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ICD-10 code
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O24.9
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ICD-10 code description
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Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
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Description
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Hs-CRP
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
2
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Description
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Newborns PPAR-gamma
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Timepoint
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Cord blood of newborns of women with GDM at delivery time
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Method of measurement
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PCR-RT
Secondary outcomes
1
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Description
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Total antioxidant capacity
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
2
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Description
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Nitric oxide
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
3
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Description
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Glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
4
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Description
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Newborns' weight
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Timepoint
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The first 24 h after birth
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Method of measurement
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Scale
5
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Description
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Newborn length
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Timepoint
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The first 24 h after birth
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Method of measurement
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Girth measuring tape
6
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Description
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Newborn head circumference
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Timepoint
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The first 24 h after birth
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Method of measurement
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Girth measuring tape
7
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Description
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Polyhydramnios
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Timepoint
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Post-intervention
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Method of measurement
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Sonography
8
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Description
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Newborns GLUT
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Timepoint
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Cord blood of newborns of women with GDM at delivery time
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Method of measurement
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PCR-RT
Intervention groups
1
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Description
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Intervention group: Zinc capsule, 30 mg, daily for 6 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo capsule, daily for 6 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available